EUROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Health Systems and products
Brussels, (2015) Revision 12
eAF Version Number: 1.20.0.2
NOTICE TO APPLICANTS
Medicinal Products for Human Use
VOLUME 2B
Module 1.2: Administrative information Application form
September 2015
This application form will be included in:
The Rules governing Medicinal Products in the European Union
The Notice to Applicants - Volume 2B - Common Technical Document - Module1 - Administrative information
To be noted:
Mandatory use of electronic Application Forms for Centralised Procedure that explains parts in light grey. As from 01/01/2016, mandatory use of electronic application forms for all procedures
Revision 12
Update from September 2015 of section 1.4.1; taking into account the review of chapter 1 of July
2015.
TABLE OF CONTENTS
DECLARATION AND SIGNATURE 1. TYPE OF APPLICATION
1.1 This application concerns
1.2 Orphan medicinal product information
1.3 Application for a change to existing marketing authorisation leading to an extension as referred to in Annex I of Regulations (EC) no 1234/2008, or any national legislation, where applicable
1.4 This application submitted in accordance with the following Article in Directive 2001/83/EC
1.5 Consideration of this application also requested under the following article in Directive 2001/83/EC or Regulation (EC) N° 726/2004
1.6 Requirements according to Regulation (EC) No 1901/2006 ('Paediatric Regulation')
2. MARKETING AUTHORISATION APPLICATION PARTICULARS
2.1 Name(s) and ATC code
2.2 Strength, pharmaceutical form, route of administration, container and pack sizes 2.3 Legal status
2.4 Marketing authorisation holder / Contact persons / Company 2.5 Manufacturers
2.6 Qualitative and quantitative composition
3. SCIENTIFIC ADVICE
4. OTHER MARKETING AUTHORISATION APPLICATIONS
4.1 For National/MRP/DCP applications, please complete the following in accordance with Article 8(j)-(l) of Directive 2001/83/EC
4.2 Marketing authorisation applications for the same product in the EEA (same
qualitative and quantitative composition in active substance(s) and having the same pharmaceutical form from applicants belonging to the same mother company or group of companies OR which are "licensees").
4.3 For multiple/duplicate applications of the same medicinal product
4.4 Marketing authorisation applications for the same product outside the EEA (i.e from applicants belonging to the same mother company or group of companies OR which are "licensees". Same qualitative and quantitative composition in active substance(s) and having the same pharmaceutical form).
5. ANNEXED DOCUMENTS (where appropriate)
FORM VALIDATION
APPLICATION FORM SUMMARY OF THE DOSSIER
APPLICATION FORM : ADMINISTRATIVE DATA
The application form is to be used for an application for a marketing authorisation of a medicinal product for human use submitted to (a) the European Medicines Agency under the centralised procedure or (b) a Member State (as well as Iceland, Liechtenstein and Norway) under either a national, mutual recognition procedure or decentralised procedure.
Usually a separate application form for each strength and pharmaceutical form is required.
For centralised procedures a combined application form is acceptable (information on each pharmaceutical form and strength should be provided successively, where appropriate).
DECLARATION AND SIGNATURE
Product (invented) name Vizitrav Duo 40 micrograms/mL + 5 mg/mL eye drops, solution
+ —
Pharmaceutical Form: Eye drops, solution
+ —
Strength:
40
Units
μg/ml
+ —
Strength:
5
Units
mg/ml
+ —
Active Substance(s):
TRAVOPROST TIMOLOL MALEATE
Add Active Substance (s)
Populate data in sections 2.1.2, 2.2.1 and 2.6.1
Applicant PharmaSwiss Česká republika s.r.o.
Title Mrs First Name Surname
Address 1 Jankovcova 1569/2c Address 2 Prague 7
Postcode Country Telephone Telefax E-mail
(name of: city, town, village, etc) 170 00
Czech Republic +420 +420
@valeant.com
Person authorised for communication*, on behalf of the Applicant:
Title Ms First name
Surname
It is hereby confirmed that all existing data which are relevant to the quality, safety and efficacy of the medicinal product have been supplied in the dossier, as appropriate and that such data are not subject to regulatory data exclusivity in the Union.
It is hereby confirmed that fees will be paid/have been paid according to the national/European Union rules**.
On behalf of the applicant
Copy contact details from previous section
Title Ms
First name*
Surname Function
Global Project Management Coordinator Address 1 6, Dervenakion str.
Address 2 Pallini, Attiki
Postcode Country Telephone Telefax E-mail
(name of: city, town, village, etc) 153 51
Greece +30
+30
@pharmathen.com Date
2016-09-29 Signatory
*
Note: please attach letter of authorisation for communication/signing on behalf of the applicant in (Annex 5.4)**
Note: if fees have been paid, attach proof of payment in - see information on fee payments on EMA/CMDhwebsite. (Annex 5.1)
1. TYPE OF APPLICATION
Note: The following sections should be completed where appropriate.
1.1 THIS APPLICATION CONCERNS
1.1.1 A CENTRALISED PROCEDURE (according to Regulation (EC) No 726/2004) 1.1.2 A MUTUAL RECOGNITION PROCEDURE (according to Article 28(2) of Directive 2001/83/EC)
1.1.3 A DECENTRALISED PROCEDURE
(according to Article 28(3) of Directives 2001/83/EC) Reference Member State Denmark
Procedure number: DK/H/2713/001/DC
Concerned Member State (specify) Poland Concerned Member State (specify) France Concerned Member State (specify) Netherlands Concerned Member State (specify) Belgium Concerned Member State (specify) Luxembourg Concerned Member State (specify) Germany Concerned Member State (specify) Spain Concerned Member State (specify) Bulgaria Concerned Member State (specify) Hungary Concerned Member State (specify) Slovakia Concerned Member State (specify) Greece Concerned Member State (specify) Romania Concerned Member State (specify) Lithuania Concerned Member State (specify) Estonia Concerned Member State (specify) Portugal Proposed/Agreed common renewal
date 5 years from D210 of the DCP
1.1.4 A NATIONAL PROCEDURE
1.2 ORPHAN MEDICINAL PRODUCT DESIGNATION
1.2.1 HAS ORPHAN DESIGNATION BEEN APPLIED FOR THIS MEDICINAL PRODUCT?
Yes No
1.2.2 INFORMATION RELATING TO ORPHAN MARKET EXCLUSIVITY
Has any medicinal product been designated as an Orphan medicinal product for a condition relating to the indication proposed in this application?
Yes No
1.3 APPLICATION FOR A CHANGE TO EXISTING MARKETING AUTHORISATION LEADING TO AN EXTENSION AS REFERRED TO IN ANNEX I OF REGULATIONS (EC) NO
1234/2008, OR ANY NATIONAL LEGISLATION , WHERE APPLICABLE?
Yes (complete sections below and also complete 1.4 +
1.6) No (complete section 1.4 + 1.6)
1.4 APPLICATION IS SUBMITTED IN ACCORDANCE WITH THE FOLLOWING ARTICLE IN DIRECTIVE 2001/83/EC
2Note: Section to be completed for any application, including applications referred to in section 1.3 For further details, refer to Notice of Applicants, Volume 2A, Chapter 1
1.4.1 Article 8(3) application, (i.e dossier with administrative, quality, pre-clinical and clinical data*) 1.4.2 Article 10(1) generic application
1.4.3 Article 10(3) hybrid application
Note: Application for a medicinal product referring to a so-called reference medicinal product with a Marketing Authorisation in a Member State or in a Union (e.g. different pharmaceutical form, different therapeutic use ...)
Complete administrative and quality data, appropriate preclinical and clinical data.
Refer to Notice to Applicants, Volume 2A, Chapter 1.
Reference medicinal product:
Note: The chosen reference medicinal product must be a medicinal product authorised in the Union on the basis of a complete dossier in accordance with the provisions of the Article 8 of Directive 2001/83/EC.
.
Medicinal product which is or has been authorised in accordance with Union provisions in force for not less than 6/10 years in the EEA:Note: This section defines the reference medicinal product chosen for the purposes of establishing the expiry of the data protection period.
Product (invented) name DuoTrav
Pharmaceutical form(s) Eye drops, solution + —
Strength(s) 40 μg/ml / 5 mg/ml
Marketing authorisation holder
Alcon Laboratories (UK) Ltd
Marketing authorisation number
EU/1/06/338/001-003
Date of authorisati on2006-04-26
+ —
Marketing authorisation granted by Union
Member State(EEA)
.
Medicinal product authorised in the Union/Member State where the application is made or European reference medicinal product:Member State(s) Denmark + —
Member State(s) Poland + —
Member State(s) France + —
Member State(s) Netherlands + —
Member State(s) Belgium + —
Member State(s) Luxembourg + —
Member State(s) Germany + —
Member State(s) Spain + —
Member State(s) Bulgaria + —
Member State(s) Hungary + —
Member State(s) Slovakia + —
Member State(s) Greece + —
Member State(s) Romania + —
Member State(s) Lithuania + —
Member State(s) Estonia + —
Member State(s) Portugal + —
Product (invented) name Duotrav
Pharmaceutical form(s) Eye drops, solution + —
Strength(s) 40 μg/ml / 5 mg/ml
Marketing authorisation holder (note 4)
Alcon Laboratories (UK) Ltd
Marketing authorisation number
EU/1/06/338/001-006
+ —
Marketing authorisation granted by Union
Member State(EEA)
.
Difference(s) compared to this reference medicinal product:changes in the active substance(s) change in therapeutic indications change in pharmaceutical form
change in strength(quantitative change to the active substance(s)) change in route of administration
bioequivalence cannot be demonstrated through bioavailability studies
.
Medicinal product which is or has been authorised in accordance with Union provisions in force used for the demonstration of bioequivalence (if applicable) and/or in other studies:Study reference number/EudraCT number
Product (invented) name
Pharmaceutical form(s) + —
Strength(s) Marketing authorisation
holder (note 4) Marketing authorisation
number + —
Marketing authorisation granted by Union
Member State(EEA) Member State of source
Note: Section to be duplicated for each product used for the demonstration of bioequivalence and/or in other studies.
1.4.4 Article 10(4) similar biological application 1.4.5 Article 10a well-established use application
Note: For further details, refer to Notice to Applicants, Volume 2A, Chapter 1.
1.4.6 Article 10b fixed combination application
Note: Complete administrative and complete quality, pre-clinical and clinical data on the combination only; for further details refer to Notice of Applicants, Volume 2A, Chapter 1.
For extensions of fixed combination applications, cross references can only be made to pre-clinical and clinical data 1.4.7 Article 10c informed consent application
Note: - Application for a medicinal product possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form of an authorised product where consent has been given by the existing marketing authorisation holder to use their data in support of this application
- Complete administrative data should be provided with consent to pharmaceutical, preclinical and clinical data - The authorised product and the informed consent application can have the same or different MAH
1.4.8 Article 16a Traditional use registration for herbal medicinal product Note: Complete application
Refer to Notice to Applicants, Volume 2A, Chapter 1
1.5 CONSIDERATION OF THIS APPLICATION REQUESTED UNDER THE FOLLOWING ARTICLE DIRECTIVE 2001/83/EC OR REGULATION (EC) NO 726/2004
31.5.1 Conditional Approval
Note: centralised procedure only according to Article 14(7) of Regulation (EC) No 726/2004 and Commission Regulation (EC) No 507/2006 1.5.2 Exceptional Circumstances
Note: According to Article 22 of Directive 2001/83/EC and Article 14(8) of Regulation (EC) No 726/2004 1.5.3 Accelerated Review
Note: Centralised procedure only according to Article 14(9) of Regulation (EC) No 726/2004
1.5.4 Article 10(1) of Directive 2001/83/EC / Article 14(11) of Regulation (EC) No 726/2004 (one year of market protection for a new indication)
1.5.5 Article 10(5) of Directive 2001/83/EC (one year of data exclusivity for a new indication)
1.5.6 Article 74(a) of Directive 2001/83/EC (one year of data exclusivity for a change in classification)
1.6 REQUIREMENTS ACCORDING TO REGULATION (EC) No 1901/2006 ('PAEDIATRIC REGULATION')
Sections 1.6.1, 1.6.2 and 1.6.3 not applicable for well-established use, generic, hybrid and bio-similar applications and traditional herbal medicinal products
1.6.4 ARTICLE 30 (PUMA) OF THE PAEDIATRIC REGULATION APPLIES TO THIS APPLICATION:
(Note: Also applies to Extension applications of PUMA)
1.6.5 HAS THIS APPLICATION BEEN SUBJECT TO PIP COMPLIANCE VERIFICATION?
Yes No Not Applicable
2. MARKETING AUTHORISATION APPLICATION PARTICULARS
2.1 NAME(S) AND ATC CODE
2.1.1 Proposed (invented) name of the medicinal product in the European Union/Member State/ Iceland/ Liechtenstein/
Norway:
Vizitrav Duo 40 micrograms/mL + 5 mg/mL eye drops, solution (Value populated from the "Declaration" section.)
If different (invented) names in different Member States are proposed in a mutual recognition or decentralised procedure, these should be listed in (Annex 5.19)
2.1.2 Name of the active substance(s)
Note: Only one name should be given in the following order of priority: INN*, Ph.Eur., National Pharmacopeia, common name, scientific name;
* The active substance should be declared by its recommended INN, accompanied by its salt or hydrate form if relevant (for further details, consult the Guideline on the SPC)
(The value of the active substances field has been populated from "Declaration" section.)
Active Substance +
TIMOLOL MALEATE —
TRAVOPROST —
2.1.3 Pharmacotherapeutic group (Please use current ATC code) ATC codeS01ED51
Group timolol, combinations
If no ATC code has been assigned, please indicate if an application for ATC code has been made
2.2 STRENGTH, PHARMACEUTICAL FORM, ROUTE OF ADMINISTRATION, CONTAINER AND PACK SIZES
2.2.1 Strength and pharmaceutical form (use current list of standard terms - European Pharmacopoeia) (The values of the following fields have been populated from "Declaration" section.)
Pharmaceutical Form: Eye drops, solution Strength:
40
Units
μg/ml
Strength:
5
Units
mg/ml
Active Substance(s):
TRAVOPROST TIMOLOL MALEATE
2.2.2 Route(s) of administration (use current list of standard terms - European Pharmacopoeia)
Route of Administration Ocular use
For each type of pack give:
2.2.3.1 Package Size 11 bottle of 2.5ml of the ophthalmic solution 2.2.3.1 Package Size 23 bottles of 2.5ml of the ophthalmic solution
Note: For mutual recognition and decentralised procedures, all package sizes authorised in the Reference Member State should be listed
Description
the preservative free eye drops, solution is packaged in a cardboard box marked with respective variable data (Lot, Exp) containing a white plastic bottle with ophthalmic dispenser.
The multi – dose container can be available in an overwrap, inside the carton box.
The primary packaging material is comprised by a 5ml PP bottle and a dispensing system which is prepared by Aeropump under the name 3K valve.
Each dispenser contains ≥2.5ml of solution and is tested on long term stability.
The primary packaging components are sterilized with ethylene oxide outsourced.
For each container give:
Container Bottle
Material PP bottle
Closure Valve
Administration Device
2.2.3.2 Proposed shelf life 36 Months
For numeric values, please use the full stop as the decimal separator. i.e. 0.002, rather than 0,002 2.2.3.3 Proposed shelf life
(after first opening container) 28 Days
For numeric values, please use the full stop as the decimal separator. i.e. 0.002, rather than 0,002 2.2.3.4 Proposed shelf life
(after reconstitution or dilution)
For numeric values, please use the full stop as the decimal separator. i.e. 0.002, rather than 0,002 2.2.3.5 Proposed storage conditions
This medicinal product does not require any special temperature storage conditions
2.2.3.6 Proposed storage conditions after first opening
This medicinal product does not require any special storage conditions
Attach a list of Mock-ups or Samples/specimens sent with the application, as appropriate (see EMA/
CMDh websites) (Annex 5.17)
2.2.4 The medical product incorporates, as an integral part, one or more medical devices within the meaning of Article 1(2)(a) of Directive 93/42/EEC or one or more active implantable medical devices within the meaning of Article 1(2)(c) of Directive 90/385/EEC
Yes
2.3 LEGAL STATUS
2.3.1 Proposed dispensing/classification
(Classification under Article 1(19) of Directive 2001/83/EC)
all pack sizes
Add Selected
?
European Union/Member State Denmark European Union/Member State Poland European Union/Member State France European Union/Member State Netherlands European Union/Member State Belgium European Union/Member State Luxembourg European Union/Member State Germany European Union/Member State Spain European Union/Member State Bulgaria European Union/Member State Hungary European Union/Member State Slovakia European Union/Member State Greece European Union/Member State Romania European Union/Member State Lithuania European Union/Member State Estonia European Union/Member State Portugal
Not subject to medical prescription (Complete 2.3.3 & 2.3.4) 2.3.2 For products subject to medicinal prescription
Product on prescription which may be renewed (if applicable)
Add Selected
?
Member State Denmark Member State Poland Member State France Member State Netherlands Member State Belgium Member State Luxembourg Member State Germany Member State Spain Member State Bulgaria Member State Hungary Member State Slovakia Member State Greece
Member State Lithuania Member State Estonia Member State Portugal
Product on prescription which may not be renewed (if applicable) Product on special prescription*
Product on restricted prescription*
(Not all the listed options are available in each member state. Applicants are invited to indicate which categories they are requesting, however, the Member States reserve the right to apply only those categories provided for in their national legislation)
Note: *For further information, please refer to Article 71 of Directive 2001/83/EC
2.3.3 Supply for products not subject to medical prescription Supply through pharmacies only
Supply through non-pharmacy outlets and pharmacies (if applicable) 2.3.4 Promotion for products not subject to medical prescription
Promotion to health care professionals only
Promotion to general public and health care professionals
2.4 MARKETING AUTHORISATION HOLDER / CONTACT PERSONS / COMPANY
2.4.1 Proposed marketing authorisation holder/person legally responsible for placing the product on the market in the European Union/each MS
Centralised procedure National procedure including mutual recognition/decentralised procedure
Copy contact details from Declaration Section
Add Selected
?
Member State Denmark Member State Bulgaria Member State Spain Member State Hungary Member State Poland Member State Estonia Member State Greece Member State Lithuania Member State Romania Member State Slovakia Member State Portugal
Company namePharmaSwiss Česká republika, s.r.o.
Address 1 Address 2
Postcode Country Telephone Telefax E-mail
Jankovcova 1569/2c Prague 7
(name of: city, town, village, etc) 170 00
Czech Republic +420
+420
czech.info@valeant.com
Attach proof of establishment of the applicant/MAH in the EEA (Annex 5.3) Has SME status been assigned by the EMA?
Yes No
Proof of payment (when relevant)
Have all relevant fees been prepaid to competent authorities?
Yes (for fees paid, attach proof of payment in) No
(Annex 5.1)
Copy address from above address details
Add Selected
?
For Member State Denmark Billing address (when relevant)
Company nameValeant Sp. z o.o. sp. jawna VAT number 8133676203
Address 1 Przemyslowa 2 Address 2 Rzeszow
(name of: city, town, village, etc) Postcode 35-959
Country Poland Telephone
Telefax n/a
Purchase order(PO) number n/a
Yes (for fees paid, attach proof of payment in) No
(Annex 5.1)
For Member State Poland For Member State Spain For Member State Bulgaria For Member State Hungary
For Member State Estonia For Member State Greece For Member State Lithuania For Member State Romania For Member State Slovakia For Member State Portugal
Copy contact details from Declaration Section Member State Belgium
Member State Netherlands Member State Luxembourg
Company nameBausch & Lomb Pharma Address 1 Bvd Lambermontlaan 430 Address 2 Brussel
(name of: city, town, village, etc) Postcode B-1030
Country Belgium Telephone
Telefax E-mail
0032 n/a
regulatory.benelux@bausch.com
Attach proof of establishment of the applicant/MAH in the EEA (Annex 5.3) Has SME status been assigned by the EMA?
Yes No
Proof of payment (when relevant)
Have all relevant fees been prepaid to competent authorities?
Yes (for fees paid, attach proof of payment in) No
(Annex 5.1)
Copy address from above address details
Add Selected
?
For Member State Netherlands Billing address (when relevant)
Company nameBausch & Lomb Pharma VAT number n/a
Address 1 Bvd Lambermontlaan 430 Address 2 Brussel
(name of: city, town, village, etc) Postcode B-1030
Country Belgium Telephone 0032
Telefax n/a
E-mail regulatory.benelux@nausch.com Purchase order(PO) number n/a
Yes (for fees paid, attach proof of payment in) No
(Annex 5.1)
For Member State Belgium For Member State Luxembourg
Copy contact details from Declaration Section Member State Germany
Company nameDr. Gerhard Mann chem.-pharm
Address 1 Fabrik GmbH, Brunsbütteler Damm 165-173 Address 2 Berlin
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
13581 Germany +49 +49
@bausch.com
Attach proof of establishment of the applicant/MAH in the EEA (Annex 5.3) Has SME status been assigned by the EMA?
Yes No
Proof of payment (when relevant)
Have all relevant fees been prepaid to competent authorities?
Yes (for fees paid, attach proof of payment in) No
(Annex 5.1)
Copy address from above address details
Add Selected
?
For Member State Germany Billing address (when relevant)
Company nameValeant Sp. z o.o. sp. jawna VAT number 8133676203
Address 1 Przemyslowa 2 Address 2 Rzeszow
(name of: city, town, village, etc) Postcode 35-959
Country Poland Telephone +48
Telefax n/a
Purchase order(PO) number n/a
Copy contact details from Declaration Section Member State France
Company nameLaboratoire CHAUVIN
Address 1 416 rue Samuel Morse CS 99535 Address 2 MONTPELLIER Cedex 2
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
34961, France +33 + 33
Attach proof of establishment of the applicant/MAH in the EEA (Annex 5.3) Has SME status been assigned by the EMA?
Yes No
Proof of payment (when relevant)
Have all relevant fees been prepaid to competent authorities?
Yes (for fees paid, attach proof of payment in) No
(Annex 5.1)
For Member State France
2.4.2 Person/company authorised for communication on behalf of the applicant during the procedure in the European Union/
each MS
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Add Selected
?
Member State(s) Denmark Member State(s) Poland Member State(s) France Member State(s) Netherlands Member State(s) Belgium Member State(s) Luxembourg Member State(s) Germany Member State(s) Spain Member State(s) Bulgaria Member State(s) Hungary Member State(s) Estonia Member State(s) Greece Member State(s) Lithuania Member State(s) Romania Member State(s) Slovakia Member State(s) Portugal
The below applicant details relates to all member states selected, if the applicant details are different for each member states then please repeat section.
Title Ms
First name Surname
Company namePharmathen S.A Address 1 44 Kifissias Avenue Address 2 Marousi, Attiki
Postcode Country Telephone Telefax E-mail
(name of: city, town, village, etc) 151 25
Greece +30 +30
@pharmathen.com
If different to 2.4.1 above, attach letter of authorisation (Annex 5.4)
2.4.3 Person/company authorised for communication between the marketing authorisation holder and the competent authorities after authorisation if different from 2.4.2 in European Union/each MS
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Add Selected
?
Member State
(s) Denmark
Title Ms
First name Surname
Company namePharmaSwiss Česká republika s.r.o.
Address 1 Jankovcova 1569/2c Address 2 Prague 7
Postcode Country Telephone Telefax E-mail
(name of: city, town, village, etc) 170 00
Czech Republic +420
+420
@valeant.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) Bulgaria
Title Ms
First name Surname
Company namePharmaSwiss EOOD Address 1 16, Troyanski prohod Str., Address 2 fl.3, ap. 8&10, Lagera, 1612 Sofia
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
1612 Bulgaria + 359 +359
@valeant.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) Germany
Title Ms First name
Surname
Company nameDr. Gerhard Mann chem.-pharm. Fabrik GmbH Address 1 Brunsbütteler Damm 165-173
Address 2 Berlin
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
13581 Germany +49 +49
@bausch.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) Belgium
Member State
(s) Netherlands
Member State
(s) Luxembourg
The below applicant details relates to all member states selected, if the applicant details are different for each member states then please repeat section.
Title Ms
First name Surname
Company nameBausch&Lomb Pharma Address 1 Bvd Lambermontlaan 430 Address 2 n/a
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
1030 Belgium 00 32 n/a
regulatory.benelux@bausch.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) France
Title Ms First name
Surname
Company nameLaboratoire CHAUVIN Address 1 416 rue Samuel Morse Address 2 CS 99535 - MONTPELLIER
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
34961 France + 33 + 33
@bausch.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) Hungary
Title First name Surname
Company nameValeant Pharma Magyarország Kft.
Address 1 Budapest, Csatárka út 82-84 Address 2 n/a
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
1025 Hungary
If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) Spain
Title First name Surname
Company nameBausch & Lomb S.A.
Address 1 Avda. Valdelaparra 4.
Address 2 Alcobendas, Madrid
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
28108 Spain +34 +34
@bausch.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) Poland
Title Ms
First name Surname
Company nameVP Valeant Sp. z o.o. sp.j.
Address 1 Marynarska 15 Address 2 Warszawa
Postcode Country Telephone Telefax E-mail
(name of: city, town, village, etc) 02-674
Poland +48 +48
@valeant.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) Estonia
Title Mr
First name
Company namePharmaSwiss Eesti OÜ Address 1
Address 2
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
11316 Estonia +372 n/a
@valeant.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) Greece
Title Mr
First name Surname
Company namePharmaswiss Hellas A.E.
Address 1 53 Pentelis Ave.
Address 2 Vrilissia
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
15235 Greece
@valeant.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) Lithuania
Title Mr
First name Surname
Company nameUAB”PharmaSwiss”
Address 1 Šeimyniškių 21B Address 2 n/a
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
09200 Lithuania + 370 +370
@valeant.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) Romania
Title Mrs
First name Surname
Company nameValeant Pharma SRL
Address 1 Maria Rosetti street, no 6, 7th floor, District 2 Address 2 Bucharest
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
020485 Romania +40 +40
@valeant.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) Slovakia
Title Mrs
First name Surname
Company nameValeant Slovakia s.r.o.
Address 1 Address 2
Postcode Country Telephone Telefax E-mail
Galvaniho 7/B, Bratislava
(name of: city, town, village, etc) 821 04
Slovakia + 421 n/a
@valeant.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
Copy contact details from 2.4.1 Section Copy contact details from Declaration Section
Member State
(s) Portugal
Title Mrs
First name Surname
Company nameBausch & Lomb S.A. – Suc. Portugal Address 1 Av. da República, nº 25, 6-A.
Address 2 Lisboa
Postcode Country Telephone Telefax E-mail
(name of: city, town, village, etc) 1050-186
Portugal + 351 + 351
@bausch.com If different to 2.4.1 above, attach letter of
authorisation (Annex 5.4)
2.4.4 Summary of the applicant pharmacovigilance system Qualified person in the EEA for Pharmacovigilance
Copy contact details from 2.4.2 Section
Add Selected
?
Member State(s) Denmark Member State(s) Poland Member State(s) France Member State(s) Netherlands Member State(s) Belgium Member State(s) Luxembourg
Member State(s) Germany Member State(s) Spain Member State(s) Bulgaria Member State(s) Hungary Member State(s) Estonia Member State(s) Greece Member State(s) Lithuania Member State(s) Romania Member State(s) Slovakia Member State(s) Portugal Title
First name Surname
Company name Address 1 Address 2
Postcode Country
24 H Telephone Telefax
The above-mentioned qualified person resides6 and operates in the EEA The qualified person is registered with Eudravigilance
Copy contact details from 2.4.2 Section
Pharmacovigilance system master file Number
Address 1 Address 2
(name of: city, town, village, etc) Postcode
Country
Note: For Risk Management Plan, see module 1, 1.8.2
6For the purposes of this application form, a Qualified Person Responsible for Pharmacovigilance “resides” in the place where he/she makes his/
her home, where he/she lives, can be traced, located, identified for all legal and contractual obligations, whether or not it is owned by him/her or he/she is permanently dwelling there.
2.4.5 Scientific service of the MAH in the EEA as referred to in Article 98 of Directive 2001/83/EC (for DCP, MRP and national applications, the contact person in the country where the application is made)
European Union/Member State where application is madeDenmark Name of the contact person
Title Dr
First name Surname
Company nameValeant sp. z o.o. sp. j.
Address 1 Al. Szucha 13/15 Address 2 Warszawa
Postcode Country Telephone Telefax E-mail
(name of: city, town, village, etc) 00-580
Poland +48 +48
@valeant.com
Add Selected
?
European Union/Member State where application is madeBulgaria Name of the contact person
Title Ms
First name Surname
Company namePharmaSwiss EOOD
Address 1 16, Troyanski prohod Str., fl.3, ap. 8&10, Lagera Address 2 Sofia
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
1612 Bulgaria +359 +359
@valeant.com
Add Selected
?
European Union/Member State where application is madeFrance Name of the contact person
Title Ms
First name Surname
Company nameLaboratoire Chauvin
Address 1 416 rue Samuel Morse - CS 99535 Address 2 MONTPELLIER Cedex 2
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
34961 France + 33 + 33
@bausch.com
Add Selected
?
European Union/Member State where application is madeBelgium European Union/Member State where application is madeNetherlands European Union/Member State where application is madeLuxembourg Name of the contact person
Title Ms
First name Surname
Company nameBausch&Lomb Pharma Address 1 Bvd Lambermontlaan 430 Address 2 n/a
Postcode Country Telephone Telefax E-mail
(name of: city, town, village, etc) 10 30
Belgium 00 32
n/a
regulatory.benelux@bausch.com
Add Selected
?
European Union/Member State where application is madeGermany Name of the contact person
Title Mr
First name Surname
Company nameDr.Gerhard Mann chem.-pharm. Fabrik GmbH Address 1 Brunsbütteler Damm 165 – 173,
Address 2 Berlin
(name of: city, town, village, etc) Postcode
Country Telephone Telefax
13581 Germany +49 n/a
Add Selected
?
European Union/Member State where application is madeHungary Name of the contact person
Title Mrs
First name Surname
Company nameValeant Pharma Magyarorszag Kft.
Address 1 Csatárka u. 82-84 Address 2 Budapest
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
1025 Hungary +36 +36
@valeant.com
Add Selected
?
European Union/Member State where application is madeSpain Name of the contact person
Title Ms
First name Surname
Company nameBausch & Lomb S.A.
Address 1 Avda. Valdelaparra 4 Address 2 Alcobendas, Madrid
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
28108 Spain (+34) n/a
@bausch.com
Add Selected
?
European Union/Member State where application is madePoland Name of the contact person
Title Mr
First name Surname
Company nameValeant sp. z o.o. sp. j.
Address 1 Address 2
Postcode Country Telephone Telefax E-mail
Al. Szucha 13/15 Str., Warsaw
(name of: city, town, village, etc) 00-580
Poland +48 +48
@valeant.com
Add Selected
?
European Union/Member State where application is madeEstonia Name of the contact person
Title Mr
First name Surname
Company namePharmaSwiss Eesti OÜ Address 1 Tammsaare tee 47 Address 2 Tallinn
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
11316 Estonia +372 n/a
@valeant.com
Add Selected
?
European Union/Member State where application is madeGreece Name of the contact person
Title Mr
First name Surname
Company namePharmaswiss Hellas A.E.
Address 1 53 Pentelis Ave.
Address 2 Vrilissia
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
15235 Greece +30210 +30 210
@valeant.com
Add Selected
?
European Union/Member State where application is madeLithuania Name of the contact person
Title Mr
First name Surname
Company nameUAB”PharmaSwiss”
Address 1 Šeimyniškių 21B Address 2 n/a
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
09200 Lithuania + 370 +370
@valeant.com
Add Selected
?
European Union/Member State where application is madeRomania Name of the contact person
Title Ms
First name Surname
Company nameValeant Pharma SRL
Address 1 Maria Rosetti street, no 6, 7th floor, District 2 Address 2 Bucharest
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
020485 Romania +40 +40
@valeant.com
Add Selected
?
European Union/Member State where application is madeSlovakia Name of the contact person
Title Ms
First name Surname
Company nameValeant Slovakia s.r.o.
Address 1 Address 2
Postcode Country Telephone Telefax E-mail
Galvaniho 7/B, Bratislava
(name of: city, town, village, etc) 821 04
Slovakia + 421 n/a
@valeant.com
Add Selected
?
European Union/Member State where application is madePortugal Name of the contact person
Title Mrs
First name Surname
Company nameBausch & Lomb S.A.
Address 1 Avda. Valdelaparra 4.
Address 2 Alcobendas, Madrid
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
28108 Spain (+34) n/a
@bausch.com
2.5 MANUFACTURERS
Note: ALL manufacturing and control sites mentioned throughout the whole dossier MUST be consistent regarding their names, detailed addresses and activities.
2.5.1 a Authorised manufacturer(s) (or importer(s)) responsible for batch release in the EEA in accordance with Article 40 and Article 51 of Directive 2001/83/EC ( as shown in the package leaflet and where applicable in the labelling or Annex II of the Commission Decision):
all pack sizes
Do you have a separate admin and manufacturer address? Yes No
Company name Pharmathen SA Address 1 6 Dervenakion Str Address 2 Pallini,
(name of: city, town, village, etc)
Postcode 153 51
Country Greece
Telephone + 30 210 66 04 300 Telefax +30 210 66 66 749
Manufacturing Authorisation number 0000006501/15/1
Attach copy of manufacturing authorisation(s) (Annex 5.6) Or
Enter EudraGMP manufacturing authorisation reference If available
Attach latest GMP certificate (Annex 5.9) Or
Enter EudraGMP certificate reference number
all pack sizes
Do you have a separate admin and manufacturer address? Yes No
Company name JADRAN - GALENSKI LABORATORIJ d.d.
Address 1 Svilno 20, Address 2 Rijeka
(name of: city, town, village, etc)
Postcode 51000
Country Croatia
Telephone +385 51 660 700 Telefax +385 51 546 024 E-mail registracije@jgl.hr
Manufacturing Authorisation number UP/I-530-01/13-03/09 Attach copy of manufacturing authorisation(s) (Annex 5.6) Or
Enter EudraGMP manufacturing authorisation reference If available
Attach latest GMP certificate (Annex 5.9) Or
Enter EudraGMP certificate reference number
2.5.1 b Official batch release for Blood products and Vaccines
Details of the Official Medicines Control Laboratory (OMCL) or laboratory designated for the purpose of official batch release (in accordance with Articles 111(1), 113, 114(1)-(2) and 115 of Directive 2001/83/EC as amended)
Laboratory name Address 1 Address 2
(name of: city, town, village, etc) Postcode
Country Telephone Telefax E-mail
2.5.1.1 Contact person in the EEA for product defects and recalls
Company namePharmaSwiss Česká republika, s.r.o.
Title Mr
First name Surname
Address 1 PharmaSwiss Česká republika, s.r.o.
Address 2 Jankovcova 1569/2c, Prague 7 (name of: city, town, village, etc) Postcode 170 00
Country Czech Republic 24 H
Telephone: +420 Telefax
n/a
@valeant.com
Company nameLaboratoire Chauvin Title
First name Surname Address 1 Address 2
Mr
416 rue Samuel Morse CS 99535 Montpellier Cedex 2 CS 99535 Montpellier Cedex 2
(name of: city, town, village, etc) Postcode 34961
Country France 24 H
Telephone: +33 Telefax
n/a
@bausch.com
2.5.1.2Batch control Testing arrangements
Site(s) in the EEA or in countries where an MRA or other European Union arrangements apply, where batch control testing takes place as required by Article 51 of Directive 2001/83/EC:
Company nameJADRAN - GALENSKI LABORATORIJ d.d.
Address 1 Svilno 20, Address 2 Rijeka
(name of: city, town, village, etc) Postcode 51000
Country Croatia
Telephone +385 51 660 700 Telefax +385 51 546 024 E-mail registracije@jgl.hr
Brief description of control tests carried out by the laboratory(ies) concerned
(note: please see the `Compilation of Union Procedures on Inspections and Exchange of Information' document, (see pages - Interpretation of the Union Format for Manufacturer/Importer Authorisation): http://www.ema.europa.eu/docs/en_GB/
document_library/Regulatory_and_procedural_guideline/2009/10/WC500004706.pdf
Quality Control Testing - Microbiological - sterility
Attach copy of manufacturing authorisation(s) or other proof of GMP
compliance (Annex
5.6) Or
Enter EudraGMP manufacturing authorisation reference
Company namePharmathen S.A Address 1 Dervenakion 6 Address 2 Pallini
(name of: city, town, village, etc) Postcode 153 51
Country Greece
Telephone +30 210 66 04 300 Telefax +30 210 66 04 749 E-mail info@pharmathen.com
Brief description of control tests carried out by the laboratory(ies) concerned
(note: please see the `Compilation of Union Procedures on Inspections and Exchange of Information' document, (see pages - Interpretation of the Union Format for Manufacturer/Importer Authorisation): http://www.ema.europa.eu/docs/en_GB/
document_library/Regulatory_and_procedural_guideline/2009/10/WC500004706.pdf Quality Control Testing - Chemical/Physical
Quality Control Testing - Microbiological - sterility
Attach copy of manufacturing authorisation(s) or other proof of GMP
compliance (Annex
5.6) Or
Enter EudraGMP manufacturing authorisation reference
2.5.2 Manufacturer(s) of the medicinal product and site(s) of manufacture:
(Note: including manufacturing sites of any diluent/solvent presented in a separate container but forming part of the medicinal product, quality control/ in-process testing sites, immediate and outer packaging and importer(s). For each site provide the relevant information.)
Copy contact details from 2.5.1.a
bottle with solution
Do you have a separate admin and manufacturer address? Yes No
Company name JADRAN - GALENSKI LABORATORIJ d.d.
Address 1 Svilno 20, Address 2 Rijeka
(name of: city, town, village, etc)
Postcode 51000
Country Croatia
Telephone +385 51 660 700 Telefax +385 51 546 024 E-mail registracije@jgl.hr Brief description of functions performed:
(note: please see the `Compilation of Union Procedures on Inspections and Exchange of Information' document, (see pages - Interpretation of the Union Format for Manufacturer/Importer Authorisation): http://www.ema.europa.eu/docs/en_GB/
document_library/Regulatory_and_procedural_guideline/2009/10/WC500004706.pdf Processing of sterile medicinal product - aseptically prepared
Quality Control Testing - Chemical/Physical Primary packaging
Secondary packaging
Quality Control Testing - Microbiological - sterility
Site(s) is in the EEA: Site(s) is outside the EEA:
Manufacturing authorisation number 381-13-04/151-13-05 Attach copy of manufacturing authorisation(s) (Annex 5.6) Or
Enter EudraGMP Manufacturing Authorisation reference
Name of qualified person
(if not mentioned in manufacturing authorisation)
bottle with solution
Do you have a separate admin and manufacturer address? Yes No
Company name Pharmathen S.A Address 1 Dervenakion 6 Address 2 Pallini
(name of: city, town, village, etc)
Postcode 153 51
Country Greece
Telephone +30 210 66 04 300 Telefax +30 210 66 04 749 E-mail info@pharmathen.com Brief description of functions performed:
(note: please see the `Compilation of Union Procedures on Inspections and Exchange of Information' document, (see pages - Interpretation of the Union Format for Manufacturer/Importer Authorisation): http://www.ema.europa.eu/docs/en_GB/
document_library/Regulatory_and_procedural_guideline/2009/10/WC500004706.pdf Quality Control Testing - Chemical/Physical
Quality Control Testing - Microbiological - sterility Secondary packaging
Site(s) is in the EEA: Site(s) is outside the EEA:
Manufacturing authorisation number 0000006501/15/1 Attach copy of manufacturing authorisation(s) (Annex 5.6) Or
Enter EudraGMP Manufacturing Authorisation reference
Name of qualified person
(if not mentioned in manufacturing authorisation)
Attach flow chart indicating the sequence and activities of the different sites involved in the manufacturing process, including testing sites (Annex 5.8)
2.5.3 Manufacturer(s) of the active substance(s) and site(s) of manufacture
Note: All manufacturing sites involved the manufacturing process of each source of active substance, including quality control/ in-process testing sites, should be listed. Broker or supplier details alone are not acceptable. For biotech products include all sites of storage of master and working cell bank and preparation of working cell banks when relevant.
For each site provide the relevant information.
Copy contact details from 2.5.1.a Copy contact details from Declaration Section
(The values of the active substances field has been populated from "Declaration" section, hence no search button available. Please click the drop down button to see the list).
Active Substance +
TRAVOPROST —
Do you have a separate admin and manufacturer address? Yes No
Company name Address 1 Address 2
Postcode Country Telephone Telefax E-mail
Brief description of manufacturing steps performed by manufacturing site:
(note: please see the `Compilation of Union Procedures on Inspections and Exchange of Information' document, (see pages - Interpretation of the Union Format for Manufacturer/Importer Authorisation): http://www.ema.europa.eu/
docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004706.pdf Manufacture of active substance by chemical synthesis
Manufacture of active substance intermediate by chemical synthesis Quality Control Testing - Chemical/Physical
Primary Packaging of active substance
Attach flow-chart indicating the sequence and activities of the different sites involved in the manufacturing process, including batch control sites(Annex
For each active substance, attach a Qualified Person declaration that the active substance5 8) is manufactured in compliance with the principles and guidelines on good manufacturing practice for starting materials (Annex
5 22)
Has the site been inspected for GMP compliance by an EEA authority or by an authority of countries where MRA or other European Union arrangements apply within the terms of agreement?
Yes No
Has the site been inspected for GMP compliance by any other authority (including those of countries where MRA or other European Union arrangements apply but not within their respective territory)?
Yes No
Has a Ph.Eur. Certificate of suitability been issued for the active substance(s):
Yes No
Is a Active Substance Master File to be used for the active substance(s)
Yes No
Name of the ASMF holder
Name of the manufacturer if different from above
EU ASMF reference number if available
National ASMF reference number: (when applicable and only if EU ASMF reference number is not available)
Applicant part version number Date of submission
Date of last update
Name of the ASMF holder
Name of the manufacturer if different from above
EU ASMF reference number if available National ASMF reference number: (when applicable and only if EU ASMF reference number is not available)
Applicant part version number Date of submission
Date of last update
Name of the ASMF holder
Name of the manufacturer if different from above
EU ASMF reference number if available National ASMF reference number: (when applicable and only if EU ASMF reference number is not available)
Applicant part version number Date of submission
Date of last update
Name of the ASMF holder
Name of the manufacturer if different from above
EU ASMF reference number if available National ASMF reference number: (when applicable and only if EU ASMF reference number is not available)
Applicant part version number Date of submission
Date of last update
Name of the ASMF holder
Name of the manufacturer if different from above
EU ASMF reference number if available National ASMF reference number: (when applicable and only if EU ASMF reference
number is not available) Applicant part version number Date of submission
Date of last update
Name of the ASMF holder
Name of the manufacturer if different from above
EU ASMF reference number if available National ASMF reference number: (when applicable and only if EU ASMF reference number is not available)
Applicant part version number Date of submission
Date of last update
Name of the ASMF holder
Name of the manufacturer if different from above
EU ASMF reference number if available National ASMF reference number: (when applicable and only if EU ASMF reference number is not available)
Applicant part version number Date of submission
Date of last update
Name of the ASMF holder
Name of the manufacturer if different from above
EU ASMF reference number if available National ASMF reference number: (when applicable and only if EU ASMF reference number is not available)
Applicant part version number Date of submission
Date of last update
Attach letter of access for European Union/Member State authorities where the
application is made (see "European ASMF procedure for active ingredients") (Annex 5.10) Attach copy of confirmation from the manufacturer of the active substance to inform the applicant in case of modification of the manufacturing process or specifications according to Annex 1 of Directive 2001/82/EC (Annex 5.11)
Is an EMA certificate for a Vaccine Antigen Master File (VAMF) issued or submitted in accordance with Directive 2001/83/EC Annex I, Part III, being used for this MAA?
Yes No
(The values of the active substances field has been populated from "Declaration" section, hence no search button available. Please click the drop down button to see the list).
Active Substance +
TRAVOPROST —
Do you have a separate admin and manufacturer address? Yes No
Company name Address 1 Address 2
Postcode Country Telephone Telefax E-mail
Brief description of manufacturing steps performed by manufacturing site:
(note: please see the `Compilation of Union Procedures on Inspections and Exchange of Information' document, (see pages - Interpretation of the Union Format for Manufacturer/Importer Authorisation): http://www.ema.europa.eu/
docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004706.pdf Quality Control Testing - Microbiological - sterility
Quality Control Testing - Chemical/Physical -Microbiology test
-IR Identification -Optical Specific Rotation -Water content (Karl Fisher)
Attach flow-chart indicating the sequence and activities of the different sites involved in the manufacturing process, including batch control sites(Annex
For each active substance, attach a Qualified Person declaration that the active substance5 8) is manufactured in compliance with the principles and guidelines on good manufacturing practice for starting materials (Annex
5 22)
Has the site been inspected for GMP compliance by an EEA authority or by an authority of countries where MRA or other European Union arrangements apply within the terms of agreement?
Yes No
Has the site been inspected for GMP compliance by any other authority (including those of countries where MRA or other European Union arrangements apply but not within their respective territory)?
Yes No
Has a Ph.Eur. Certificate of suitability been issued for the active substance(s):
Yes No
Is a Active Substance Master File to be used for the active substance(s)
Yes No
Is an EMA certificate for a Vaccine Antigen Master File (VAMF) issued or submitted in accordance with Directive 2001/83/EC Annex I, Part III, being used for this MAA?
Yes No
(The values of the active substances field has been populated from "Declaration" section, hence no search button available. Please click the drop down button to see the list).
Active Substance +
TIMOLOL MALEATE —
Do you have a separate admin and manufacturer address? Yes No Company name
Admin Office Address 1
Admin Office Address 2
Postcode
Admin Office Country Admin Office
Telephone
Admin Office Telefax Admin Office E-mail
Company name Manufacturing Facility Address 1 Manufacturing Facility Address 2 Postcode
Manufacturing Facility Country Manufacturing Facility Telephone Manufacturing Facility Telefax Manufacturing Facility E-mail
Brief description of manufacturing steps performed by manufacturing site:
(note: please see the `Compilation of Union Procedures on Inspections and Exchange of Information' document, (see pages - Interpretation of the Union Format for Manufacturer/Importer Authorisation): http://www.ema.europa.eu/
docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004706.pdf Manufacture of active substance by chemical synthesis
Quality Control Testing - Microbiological - non-sterility
Attach flow-chart indicating the sequence and activities of the different sites involved in the manufacturing process, including batch control sites(Annex
For each active substance, attach a Qualified Person declaration that the active substance5 8) is manufactured in compliance with the principles and guidelines on good manufacturing practice for starting materials (Annex
5 22)
Has the site been inspected for GMP compliance by an EEA authority or by an authority of countries where MRA or other European Union arrangements apply within the terms of agreement?
Yes No
Has the site been inspected for GMP compliance by any other authority (including those of countries where MRA or other European Union arrangements apply but not within their respective territory)?
Yes No
Has a Ph.Eur. Certificate of suitability been issued for the active substance(s):
Yes No
Name of the CEP holder Name of the
manufacturer if different from the above
CEP number Date of last update
Provide copy in (Annex 5.10)
Is a Active Substance Master File to be used for the active substance(s)
Yes No
Is an EMA certificate for a Vaccine Antigen Master File (VAMF) issued or submitted in accordance with Directive 2001/83/EC Annex I, Part III, being used for this MAA?
Yes No
2.5.4 Contract companies used for clinical trial(s) on bioavailability or bioequivalence or used for the validation of blood product manufacturing processes. For each contract company, state where analytical tests are performed and where clinical data are collected and give: